What additional measures are taken for the viral safety of BeneFIX?
To address the theoretical possibility of a virus entering the cell-culture process and not being detected, the purification process of BeneFIX comprises several steps with the capacity to remove potential viral contaminants. For example, a membrane filtration step that has the ability to retain molecules with apparent molecular weights of >70,000 (such as large proteins and viral particles) is included for additional viral safety.1 The effectiveness of the purification process to remove potential viruses has been formally tested with the following model viruses: amphotropic murine leukemia virus (A-MuLV), bovine parvovirus (BPV), human herpes simplex virus (HSV), and reovirus type 3 (Reo-3). These model viruses represent a range of viral classes and sizes, and cover both enveloped and nonenveloped viruses. The purification steps evaluated provide significant (≥10 log10) removal of each of the model viruses tested and thus offer a wide margin of viral safety to address the theoretical
